Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2 Detection
FDA 510(k) K991955 · Engineered Medical Systems
510(k) numberK991955
Submission
- Device name
- Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2 Detection
- Applicant
- Engineered Medical Systems
Indianapolis, IN, US - Received
- June 1, 1999
- Decision date
- July 6, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTM – Ventilator, Emergency, Manual (Resuscitator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5915
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K212905 | Sotair DeviceBTM · Traditional | Safe Bvm Corporation | 08/18/2022SE |
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| K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount…BTM · Traditional | Foremount Enterprise Co., Ltd. | 05/11/2018SE |
| K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II…BTM · Abbreviated | Ambu A/S | 08/29/2016SE |
| K132172 | Neonatalie ResuscitatorBTM · Abbreviated | Laerdal Medical A/S | 01/15/2015SE |
| K112852 | Babi Plus Neonatal Resuscitation BagBTM · Traditional | A Plus Medical | 01/13/2012SE |
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Questions and answers
When was Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2 Detection cleared by the FDA?
Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2 Detection (K991955) received a 510(k) decision of Substantially Equivalent on July 6, 1999, 35 days after the submission was received.
What is the product code of K991955?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.